DiaSorin Hepatitis B Tests Need Clearer Indication Of "High-Risk" Population
This article was originally published in The Gray Sheet
Executive Summary
DiaSorin needs to distinguish between specific subgroups of high-risk patient populations in labeling of its ETI Plus line of in vitro diagnostic hepatitis B serological marker assays, FDA's Microbiology Devices Advisory Panel agreed in recommending six assays for approval at a Jan. 20 meeting in Rockville, Maryland.